Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 1 - Control | Control - no financial incentive or match Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive. | 0 | None | 0 | 33 | 0 | 33 | View |
| 2 - Deposit Contract With a 1:1 Match | Deposit contract with a 1:1 match Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made. | 0 | None | 0 | 33 | 0 | 33 | View |
| 3 - Deposit Contract With a 2:1 Match | Deposit contract with a 2:1 match Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made. | 0 | None | 0 | 33 | 0 | 33 | View |
| Experimental 4 - Deposit Contract With no Match | Deposit contract with no match Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made. | 0 | None | 0 | 33 | 0 | 33 | View |